Can Ultrasound Detect Diabetic Peripheral Neuropathy?

NCT ID: NCT01261442

Last Updated: 2012-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-02-29

Brief Summary

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The cross sectional area of posterior tibial nerve (PTN) is increased in diabetic patients with distal symmetric polyneuropathy (DSPN) as compared to diabetic patients without DSPN. This study aims to evaluate whether the cross sectional area of the Posterior Tibial Nerve (PTN) as measured by ultrasound is increased in patients with distal symmetric polyneuropathy (DSPN) as compared to diabetic patients without DSPN.

Detailed Description

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Regional anesthesia is associated with a low frequency of neurologic injury that can result in permanent deficit. It is believed that patients with neuropathies might be at higher risk of injury but detailed investigation of the diabetic patient is lacking yet anesthetic practices may be altered nevertheless. This study intends to investigate the appearance and sonographic qualities, as well as electrophysiologic measures, of the posterior tibial nerve (PTN) in diabetic patients undergoing nerve conduction studies in order to compare PTN characteristics between diabetic patients with peripheral neuropathy to those without. Ultimately, we hope that ultrasound, a commonly used non-invasive tool, will be able to assist in the identification of patients at higher risk of injury from regional anesthesia

Conditions

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Distal Symmetric Polyneuropathy (DSPN)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic patients with DSPN

Nerve Conduction Study (NCS)

Intervention Type PROCEDURE

An NCS will be performed on each patient to confirm or exclude DSPN. Following this, a systematic ultrasound examination of the posterior tibial nerve will be performed for all the patients.

Diabetic patients without DSPN

Nerve Conduction Study (NCS)

Intervention Type PROCEDURE

An NCS will be performed on each patient to confirm or exclude DSPN. Following this, a systematic ultrasound examination of the posterior tibial nerve will be performed for all the patients.

Interventions

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Nerve Conduction Study (NCS)

An NCS will be performed on each patient to confirm or exclude DSPN. Following this, a systematic ultrasound examination of the posterior tibial nerve will be performed for all the patients.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Type I diabetic patients (diagnosed more than 5 years), and type II diabetic patients scheduled for routine NCS.

Exclusion Criteria

* Non-diabetic neuropathy caused by genetic, metabolic and inflammatory diseases as well as toxic agents and drug induced (eg. chemotherapy agents)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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10-0435-BE

Identifier Type: -

Identifier Source: org_study_id

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